URESIL CAROTID SHUNT— 510(k) K863558
Substantially EquivalentUresil Corp.
FDA 510(k) clearance K863558 for URESIL CAROTID SHUNT, Substantially Equivalent on 1986-11-24. Applicant: Uresil Corp.. Device class: 2.
Clearance details
- Applicant
- Uresil Corp.
- Product code
- Code DWF
- Device class
- Class 2
- Regulation
- 21 CFR 870.4210
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Skokie, IL, US
Recent devices under product code DWF
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- K980278 — URESIL VASCU-FLO INFUSION CATHETER
- K981344 — URESIL PERCUTANEOUS DRAINAGE CATHETERS WITH HYDROPHILIC COATING
- K980282 — URESIL DILATOR WITH RADIOPAQUE MARKER
- K980889 — URESIL NEPHRO-URETERAL STENT
Adverse events under product code DWF
product code DWF- Death
- 106
- Injury
- 386
- Malfunction
- 2,323
- Total
- 2,815
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.